Catheter

ABSTRACT

A catheter including a catheter shaft that has a proximal shaft and a distal shaft. The proximal shaft and the distal shaft are joined to one another in the axial direction. The proximal and distal shafts are integrally connected to one another by the distal end of the proximal shaft being inserted into a hollow interior of the proximal end of the distal shaft or by the proximal end of the distal shaft being inserted into a hollow interior of the distal end of the proximal shaft. The proximal shaft includes a penetrating portion which penetrates from the inner surface through to the outer surface at the distal end of the proximal shaft. The distal shaft includes a projecting portion that includes a tip portion which extends through the penetrating portion past the inner or outer surface of the proximal shaft so that the tip portion is exposed.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of International Application No.PCT/JP2016/050299 filed on Jan. 7, 2016, and claims priority to JapanesePatent Application No. 2015-005105 filed on Jan. 14, 2015, the entirecontent of both of which is incorporated herein by reference.

TECHNICAL FIELD

The present invention generally relates to a catheter having a cathetershaft that is formed by joining a plurality of shafts. Morespecifically, this application relates to the shaft of a catheter thatpossesses improved joining strength. The application also relates to amethod of manufacturing the catheter.

BACKGROUND DISCUSSION

Treatment of vascular lesion using a catheter is widely performedbecause it introduces less surgical stress in a living body. Forexample, a balloon catheter is used for dilating a lesion area in acoronary artery and improving a blood flow in Percutaneous TransluminalCoronary Angioplasty (PTCA). The balloon catheter generally includes anelongated hollow catheter shaft, a balloon provided on a distal side ofthe catheter shaft, and a hub provided on a proximal side of thecatheter shaft.

The catheter shaft is required to have a pushing performance whichcontributes to reliably transmit a pushing force of an operator from aproximal side to a distal side of the catheter because the catheter maybe inserted into blood vessels having complicated curves. The cathetershaft also needs to have a followability (i.e., maneuverability) whichhelps to smoothly and reliably advance the catheter in a blood vessel ina living body along a leading guide wire. Catheters are known to beconfigured to achieve both of these properties by making a proximal sideof a catheter shaft of a material having a high flexural stiffness and adistal side of the catheter shaft of a material having less flexuralstiffness than the proximal side and being relatively highly flexible(i.e., possess relatively high flexibility), and joining both sidestogether in an axial direction. For example, Japanese Patent ApplicationNo. 2013-005976 discloses a catheter with a catheter shaft having a highflexural stiffness joined to a distal catheter shaft having lessflexural stiffness.

SUMMARY

The joint structure between the shaft on the distal side and the shafton the proximal side is generally achieved by forming one of the shaftsto have an outer diameter which allows insertion into a hollow interiorof the other shaft. The joining of the two shafts is then accomplishedby inserting an end portion of the one shaft into the hollow interior ofthe other shaft, and fixing both of the shafts to one another bycrimping, adhesion, or a combination of crimping and adhesion.

A fluid such as an X-ray contrast agent may be injected into thecatheter shaft to inflate a balloon provided at a distal portion. Thecatheter shaft thus becomes pressurized from inside. The joint portionof the shaft may thus be subjected to a force in a direction in whichthe shafts separate from each other when the fluid is injected into thecatheter shaft. Therefore, the joint portion of the shaft has a risk ofseparation or disconnection of the shafts due to this separation.Joining by means of crimping or adhesion may not ensure a joiningstrength sufficient for resisting the force of separation of the shafts.

The catheter disclosed in this application has a catheter shaft thatincludes a shaft on the proximal side and a shaft on the distal sideintegrated with one another with a high joining strength.

A catheter disclosed in this application more specifically may include acatheter shaft that has a proximal shaft and a distal shaft. Theproximal shaft and the distal shaft are joined to one another in theaxial direction. The proximal and distal shafts are integrally connectedto one another by the distal end of the proximal shaft being insertedinto a hollow interior of the proximal end of the distal shaft or by theproximal end of the distal shaft being inserted into a hollow interiorof the distal end of the proximal shaft. The proximal shaft includes apenetrating portion which penetrates from the inner surface through tothe outer surface at the distal end of the proximal shaft. The distalshaft includes a projecting portion that includes a tip portion whichextends through the penetrating portion past the inner or outer surfaceof the proximal shaft so that the tip portion is exposed.

In another aspect, the catheter includes a catheter shaft extending inan axial direction from a proximal end to a distal end. The cathetershaft includes a proximal shaft and a distal shaft that are each ahollow cylinder. The proximal end of the distal shaft is proximal to thedistal end of the proximal shaft so that the distal and proximal shaftsoverlap in the axial direction along a joint. The proximal shaft and thedistal shaft are integrally connected to one another at the joint by thedistal end of the proximal shaft being inserted into a hollow interiorof the proximal end of the distal shaft. The proximal shaft includes apenetrating portion which penetrates from the inner surface through tothe outer surface at the distal end of the proximal shaft. The distalshaft includes a projecting portion that extends radially inward fromthe inner surface of the distal shaft. The projecting portion extendsthrough the penetrating portion of the proximal shaft to the innersurface of the proximal shaft. The projecting portion includes a tipportion which extends radially inwardly beyond the inner surface of theproximal shaft.

In the catheter described above, the distal shaft includes theprojecting portion configured to penetrate from the one surface to theother surface of the proximal shaft through the penetrating portion ofthe proximal shaft. The tip portion of the projecting portion is exposedfrom the inner surface or the outer surface of the penetrating portion.The projecting portion of the distal shaft thus enters the joint portionfrom an inner surface side to an outer surface side of the proximalshaft or enters the joint portion from the outer surface side to theinner surface side of the proximal shaft, so that a high joiningstrength between the distal and proximal shafts is achieved. Thecatheter shaft may accordingly help prevent separation of the jointsurfaces of the proximal shaft and the distal shaft from each other tohelp prevent the proximal shaft and the distal shaft from disconnecting.

With a distal end portion of the proximal shaft inserted into a hollowinterior of a proximal end portion of the distal shaft, the projectingportion of the distal shaft penetrates from the outer surface side tothe inner surface side of the proximal shaft through the penetratingportion to be exposed at the inner surface of the proximal shaft. Theprojecting portion may be formed while crimping the proximal shaft andthe distal shaft easily by applying heat and pressure from outside thedistal shaft (e.g., using a shrinkable tube that covers the outersurface of the proximal end portion of the distal shaft).

The projecting portion may have a structure that does not come outeasily (i.e., separate relatively easily) from the penetrating portionbecause the tip portion of the projecting portion (exposed at the innersurface of the proximal shaft) is provided with an enlarged portionhaving a width larger than the penetrating portion (e.g., the innerdiameter of the penetrating portion). Therefore, separation of the jointsurfaces of the proximal shaft and the distal shaft from each other anddisconnection between the proximal shaft and the distal shaft may beprevented further reliably.

The penetrating portion may be formed easily on the proximal shaft byforming the penetrating portion as a hole or a slit through a peripheralsurface of the proximal shaft.

With the proximal shaft made of a metallic material and the distal shaftmade of a resin material, an effect of fixation between the proximal anddistal shafts with the projecting portion at a joint between themetallic material and the resin material by crimping is furtherimproved. More specifically, improvement of the joining strength atjoining surfaces of the metallic material and the resin material isdifficult because the metallic material and the resin material do notfuse together. However, with the catheter shaft disclosed in thisapplication, a physical joint structure at the joining surfaces of theproximal shaft and the distal shaft is achieved by using the projectingportion. The joining strength at the joining surfaces may thus beimproved.

The distal shaft may be provided with a balloon on the outer surface ofthe distal shaft at the distal end side (i.e., distal to the projectingportion). An interior of the catheter shaft of the catheter ispressurized when the balloon is inflated. The joining surfaces of theproximal shaft and the distal shaft are susceptible to separation or theproximal shaft and the distal shaft are susceptible to disconnection dueto the pressure in the interior of the catheter shaft. However, suchseparation and disconnection may reliably be prevented by joining theproximal and distal shafts as described above.

With the additional provision of a reinforcement body extending distallyfrom the distal end portion of the proximal shaft and disposing aproximal end portion of the reinforcement body distal to one or ones ofthe penetrating portions of the proximal shaft located at thedistal-most position, the reinforcement body may be extended linearlyfrom the end portion of the proximal shaft toward the distal shaftwithout interference of the reinforcement body with the projectingportion. Therefore, bending properties of the catheter shaft may not beadversely affected. When joining the proximal shaft and the distalshaft, a core bar member may additionally be prevented from interferingwith the reinforcement body, so that the reinforcement body is notdeformed.

This application also relates to a catheter shaft manufacturing methodthat includes inserting the end portion of a first catheter shaft intothe end portion of a second catheter shaft. The first and secondcatheter shafts are hollow cylinders that each possess an interior. Theinner diameter of the second catheter shaft is substantially equal tothe outer diameter of the first catheter shaft so that the inner surfaceof the second catheter shaft is located immediately adjacent to theouter surface of the first catheter shaft. The end portion of the firstcatheter shaft includes a penetrating portion. The method furtherincludes positioning a core bar within the interior of the firstcatheter shaft. The core bar possesses an outer diameter that is lessthan the inner diameter of the first catheter shaft so that a gap isbetween an outer surface of the core bar and the inner surface of thefirst catheter shaft. The method includes covering the outer surface ofthe end portion of the second catheter shaft with a shrinkable tubewhile the end portion of the first catheter shaft is within the endportion of the second catheter shaft and while the core bar is withinthe interior of the first catheter shaft, and heating the shrinkabletube to shrink the inner diameter of the shrinkable tube so that theshrinkable tube compresses the end portion of the second catheter shaftradially inward. The heating also softens a material of the secondcatheter shaft so that a portion of the material of the second catheterflows radially inward through the penetrating portion of the firstcatheter shaft. The method includes cooling the first catheter shaft andthe second catheter shaft so that a catheter shaft is formed with thefirst and second catheter shafts joined together.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a drawing illustrating a general configuration of oneembodiment of a catheter.

FIG. 2 is a cross-sectional view of a catheter shaft and a balloon.

FIG. 3 is an enlarged cross-sectional view of a portion near a jointportion of the catheter shaft.

FIG. 4 is a plan view near an end portion of a proximal shaft.

FIG. 5 is an enlarged cross-sectional view illustrating a portion nearthe joint portion in a stage in which the joint portion is covered witha shrinkable tube in a joint process for joining the proximal shaft anda distal shaft.

FIG. 6 is an enlarged cross-sectional view illustrating a portion nearthe joint portion in a stage in which the shrinkable tube shrinks in thejoint process for joining the proximal shaft and the distal shaft.

FIG. 7 is a plan view near the end portion of the proximal shaft havingpenetrating portions of another mode.

FIG. 8 is a cross-sectional view illustrating a portion near the jointportion between the proximal shaft having penetrating portions ofanother mode and the distal shaft.

DETAILED DESCRIPTION

Set forth below with reference to the accompanying drawings is adetailed description of embodiments of a catheter and method ofmanufacturing a catheter representing examples of the inventive catheterand method disclosed here. Note that dimensional ratios of the drawingsmay be exaggerated and thus may be different from actual ratios for thesake of convenience of description. In this specification, the side of acatheter 10 which is to be inserted towards or into a body lumen in aliving body is referred to as the “distal”, “distal end” or “distalside”, and a near side to be operated by an operator outside of theliving body is referred to as “proximal”, “proximal end” or “proximalside”.

The configuration of a catheter 10 will first be described. The catheter10 includes an elongated hollow catheter shaft 11, a balloon 12 providedat a distal end portion of the catheter shaft 11, and a hub 13 securedto a proximal end portion of the catheter shaft 11 as illustrated inFIG. 1.

The catheter 10 is capable of dilating (expanding or widening) a lesionarea for treatment by inserting the elongated catheter shaft 11 into abiological organ and inflating the balloon 12 provided on the distalside of the catheter shaft 11 while the balloon 12 is in the lesionarea.

The catheter shaft 11 is provided with an opening portion 41 forintroducing a guide wire 14 (i.e., configured so that a guide wire 14can be inserted through the opening portion 41) at a position biasedtoward the distal side of the catheter shaft 11. In other words, thecatheter 10 of the embodiment illustrated in FIG. 1 is a so-called rapidexchange type catheter. The catheter shaft 11 includes a proximal shaft30 on the proximal side and a distal shaft 40 on the distal side joinedto one another in an axial direction and integrated (i.e., integrallyjoined in an axially overlapping manner or interconnected).

The proximal shaft 30 and the distal shaft 40 are joined in the axialdirection at an intermediate position of the catheter shaft 11 asillustrated in FIG. 2. The distal shaft 40 has an inner diameterslightly larger than the outer diameter of the proximal shaft 30. An endportion 31 (i.e., a distal end) of the proximal shaft 30 is insertedinto an end portion 44 (i.e., a proximal end) of the distal shaft 40,and both shafts are joined together.

The distal side of the catheter shaft 11 with respect to the openingportion 41 (i.e., the portion of the catheter shaft 11 that is distal tothe opening portion 41) has a double tube structure. The double tubestructure includes an outer tube 42 and an inner tube 43 arranged in aconcentric manner. The outer tube 42 extends distally to a proximal endportion of the balloon 12 (i.e., the distal end of the outer tube 42 isat the proximal end portion of the balloon 12) and is provided with aninflation lumen 50 in an interior of the outer tube 42. Fluid forinflating the balloon 12 may be injected into the inflation lumen 50.The proximal side of the catheter shaft 11 with respect to the openingportion 41 (i.e., the portion of the catheter shaft 11 that is proximalto the opening portion 41) has a single tube structure, and the interiorthereof continues from the inflation lumen 50 in the outer tube 42.

The distal end of the inner tube 43 extends distally beyond the distalend portion of the balloon 12. The distal end of the inner tube 43 isprovided with a guide wire lumen 51 in which the guide wire 14 isconfigured to be inserted in an interior of the guide wire lumen 51.

The distal side of the balloon 12 is adhered to the inner tube 43, andthe proximal side is adhered to the outer tube 42. An interior of theballoon 12 is in communication with the inflation lumen 50. The balloon12 may thus be inflated by injection of the inflation fluid through theinflation lumen 50. The injection fluid can be gas or liquid. Forexample, gas such as helium gas, CO₂ (carbon dioxide) gas, O₂ (oxygen)gas, and liquid such as physiological salt solution and contrast agentmay be used.

The proximal shaft 30 in the embodiment of the catheter illustrated inFIG. 1 is made of a metallic material such as stainless steel andaluminum. The distal shaft 40 in the embodiment of the catheterillustrated in FIG. 1 is made of a resin material having a thermoplasticproperty. Specific examples of the distal shaft 40 material includepolyolefin such as polyethylene, polypropylene, polybutene,ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer,and mixture of two or more of these components, soft polyvinyl chlorideresin, polyamide, polyamide elastomer, polyester, polyester elastomer,polyurethane, and fluorine resin such as polytetrafluoroethylene.

Improvement of pushing performance of the catheter 11 is achievedbecause the proximal shaft 30 is made of a metallic material.Improvement of followability that ensures smooth and reliable advance ina blood vessel is achieved because the distal shaft 40 is made of aresin material. The disclosed catheter possesses a structure in whichthe proximal shaft 30 made of a metallic material and the distal shaft40 made of a resin material are joined with a high strength. This pointwill be described below.

As illustrated in FIGS. 3 and 4, the end portion 31 (distal end) of theproximal shaft 30 that is inserted into the end portion 44 (proximalend) of the distal shaft 40 is provided with penetrating portions 32that penetrate therethrough between the inner surface and the outersurface of the proximal shaft 30 (i.e., the penetrating portions 32 arethrough-holes that penetrate fully from the inner surface to the outersurface of the proximal shaft 30). The penetrating portions 32 are eachformed of a circular through hole as illustrated in FIG. 4. A pluralityof the penetrating portions 32 are formed in a circumferential directionand an axial direction of the proximal shaft 30, respectively. In theembodiment illustrated in FIGS. 3 and 4, four penetrations 32 areincluded. Two of the penetrating portions 32 are spaced apart from theother two penetrating portions 32 in the axial direction, and two of thepenetrating portions are spaced apart from the other two penetratingportions 32 at positions 180 degrees away from each other in thecircumferential direction.

The number and the positions of the penetrating portions 32 are notlimited to four penetrating portions or to the illustrated positions.The number and positions of the penetrating portions 32 may be selectedas needed depending on the required joining strength. The shape of thehole of the penetrating portions 32 is not limited to being circular,but may be other shapes such as a square shape and an oval shape.

The end portion 31 of the proximal shaft 30 and the end portion 44 ofthe distal shaft 40 are joined together by crimping. As illustrated inFIG. 3, an internal surface of the end portion 44 of the distal shaft 40is provided with projecting portions 45 that penetrate through thepenetrating portions 32 of the proximal shaft 30 from an outer surfaceside to an inner surface side (i.e., radially inward). Tip portions ofthe projecting portions 45 are exposed from the inner surface side ofthe proximal shaft 30, and each of the tip portions include an enlargedportion 45 a larger in width (i.e., wider) than the width of each of thepenetrating portions 32. In other words, the inner surface side of thedistal shaft 40 made of a resin material has a shape that enters thehollow interior of the proximal shaft 30 through the penetratingportions 32 and cannot be disconnected from the penetrating portions 32.As used herein the expression “the tip portions of the projectingportions 45 are exposed from the inner surface side of the proximalshaft 30” is intended to mean that the tip portions of the projectingportions 45 protrude to a level flush with or inner than (i.e., moreradially inward than) the inner surface of the proximal shaft 30. Inother words, the tip portions of the projecting portions 45 protrudewithout staying entirely in the interior of the penetrating portions 32.

In this manner, the joining strength between the proximal shaft 30 andthe distal shaft 40 is improved by configuring the proximal shaft 30with the penetrating portions 32 and the distal shaft 40 with theprojecting portions 45 that enter the hollow interior of the proximalshaft 30 through the penetrating portions 32. When the interior of thecatheter shaft 11 is pressurized in order to inflate the balloon 12,separation of the joint portion of the proximal shaft 30 and the distalshaft 40 from each other or disconnection between the proximal shaft 30and the distal shaft 40 may be prevented.

As the proximal shaft 30 is made of a metallic material and the distalshaft 40 is made of a resin material, the joining strength between theproximal shaft 30 and the distal shaft 40 if joint is made by crimpingis lower than when forming a joint between resins by crimping. However,sufficient joining strength may be ensured by the projecting portions 45entering the hollow interior of the proximal shaft 30 in addition tojoining by crimping.

The distal end portion of the proximal shaft 30 is provided with ametallic reinforcement body 33. The reinforcement body 33 is anelongated wire member that is joined to the hollow interior of theproximal shaft 30 by welding. The reinforcement body 33 is not limitedto a solid wire member. The reinforcement body 33 may be other shapessuch as a half pipe shaped elongated member. The proximal shaft 30 madeof a metallic material and the distal shaft 40 made of a resin materialare significantly different in flexural rigidity. Therefore, the jointportion between the proximal shaft 30 and the distal shaft 40 issusceptible to collapse and kink of the distal shaft 40. An abruptchange in flexural rigidity can be alleviated, and collapse and kink ofthe distal shaft 40 can be prevented, however by including the metallicreinforcement body 33 extending from the end portion of the proximalshaft 30 toward the distal shaft 40.

A proximal end portion of the reinforcement body 33 is distal to thepenetrating portion 32 or penetrating portions 32 of the proximal shaft30 that are disposed at a distal-most position (i.e., the reinforcementbody 33 is entirely distal to the distal-most penetrating portion(s)32). Accordingly, a core bar member 60 (described below) may beprevented from interfering with the reinforcement body 33, and thusdeformation or the like of the reinforcement body 33 may be preventedwhen forming the projecting portions 45. The bending properties (i.e.,bendability or flexibility) of the catheter shaft 11 are not adverselyaffected because the reinforcement body 33 is restricted frominterfering with the projecting portions 45 made of a resin material,and the reinforcement body 33 may be extended linearly from the distalend portion of the proximal shaft 30 toward the distal shaft 40. Theproximal end portion of the reinforcement body 33 may be distal to theprojecting portion 45 or projecting portion 45 of the distal shaft 40disposed at the distal-most position (i.e., the distal-most projectingportion(s) 45. The reinforcement body 33 may accordingly be furtherprevented from interfering with the projecting portions 45 made of aresin material.

A joint process for joining the proximal shaft 30 and the distal shaft40 to one another is next described. Prior to the joint process, theproximal shaft 30 made of a metal and having predetermined diameter andlength, and the distal shaft 40 made of a resin and having predetermineddiameter and length, are fabricated in advance. The penetrating portions32 are provided in the proximal shaft 30 in advance, and thereinforcement body 33 is joined to the distal end portion of theproximal shaft 30 by welding.

In the joint process, the distal end portion 31 of the proximal shaft 30is first inserted into the proximal end portion 44 of the distal shaft40 as illustrated in FIG. 5. The proximal shaft 30 is inserted into thedistal shaft 40 so that all of the penetrating portions 32 stay in thehollow interior of the distal shaft 40. The outer diameter of theproximal shaft 30 is formed to be equivalent to the inner diameter ofthe distal shaft 40, so that the outer surface of the proximal shaft 30is brought into substantially tight contact with the inner surface ofthe distal shaft 40. In other words, the outer diameter of the proximalshaft 30 is substantially equal to (e.g., slightly greater than) theinner diameter of the distal shaft 40 so that the outer surface of theproximal shaft is immediately adjacent (i.e., opposite) the innersurface of the distal shaft.

The core bar member 60 is inserted into the hollow interior of theproximal shaft 30. The core bar member 60 is a metallic rod member andpossesses an outer diameter that is slightly smaller than the innerdiameter of the proximal shaft 30. Therefore, a minute (relativelysmall) gap is formed between the core bar member 60 and the innersurface of the proximal shaft 30. The distal end of the core bar member60 is positioned distal to the distal-most of the penetrating portions32 of the proximal shaft 30 and proximal to the proximal end portion ofthe reinforcement body 33.

A portion where the proximal shaft 30 and the distal shaft 40 overlapwith each other is covered with a shrinkable tube 61 that shrinks bybeing heated. The shrinkable tube 61 is made of a material such aspolyolefin, which shrinks in diameter after being heated (i.e., theinner diameter of the shrinkable tube 61 after being heated is smallerthan the inner diameter of the shrinkable tube 61 before being heated).The shrinkable tube 61 thus contributes to pressurize the distal shaft40 radially inward from outside of the distal shaft 40 by being heated.In contrast, the end portion 31 of the proximal shaft 30 and the endportion 44 of the distal shaft 40 that overlap with each other arecompressed in the thickness direction of the catheter shaft 11 becausethe core bar member 60 is disposed in the hollow interior of theproximal shaft 30, so that the end portion 31 of the proximal shaft 30and the end portion 44 of the distal shaft 40 are interposed between theshrinkable tube 61 and the core bar member 60.

The joint portion between the proximal shaft 30 and the distal shaft 40is heated to a temperature at which the resin material forming thedistal shaft 40 softens. As described above, the end portion 44 of thedistal shaft 40 is crimped to the end portion 31 of the proximal shaft30 since the distal shaft 40 and the proximal shaft 30 are pressurizedin the direction of compression with the shrinkable tube 61 that shrinksby being heated. At this time, the softened resin material of the distalshaft 40 enters the interior of the penetrating portions 32 of theproximal shaft 30, penetrates through the penetrating portions 32, andenters the hollow interior of the proximal shaft 30. The resin materialof the distal shaft 40 entering the hollow interior of the proximalshaft 30 spreads in a space between the proximal shaft 30 and the corebar member 60 and forms an enlarged portion having a wider width thanthe penetrating portions 32. The projecting portions 45 having theenlarged portions 45 a are thereby formed.

The proximal shaft 30 and the distal shaft 40 are crimped together andthe projecting portions 45 are formed, so that both shafts are joinedwith a high strength (i.e., a relatively high joining force is createdbetween the proximal and distal shafts 40). After being heated, thecatheter shaft 11 is cooled to a room temperature, the core bar member60 is pulled out from the proximal shaft 30, and the shrinkable tube 61is separated from the joint portion between the proximal shaft 30 andthe distal shaft 40. The joint forming process is thus completed.

Another embodiment of the penetrating portion is next described. Asillustrated in FIG. 7, a penetrating portion 35 of this embodiment isformed by a series of slit cut into a peripheral surface of the proximalshaft 30 in a helical shape. The proximal shaft 30 is resilientlydeformed in such a manner that the helical slit opens as the proximalshaft 30 is compressed in the circumferential direction.

The proximal shaft 30 having the penetrating portion 35 of thisembodiment may be joined with the distal shaft 40 in the same process asthe proximal shaft 30 having the hole-type penetrating portions 32. Inother words, the end portion 31 (distal end) of the proximal shaft 30 isinserted into the end portion 44 (proximal end) of the distal shaft 40,the core bar member 60 is inserted into the hollow interior of theproximal shaft 30, and the joint portion is covered with the shrinkabletube 61 from the outside of the distal shaft 40. By heating the jointportion, the distal shaft 40 softens, and the shrinkable tube 61 isshrunk and compressed onto the outer surface of the distal shaft 40, sothat the resin material of the distal shaft 40 is crimped to theproximal shaft 30, and so that the resin material of the distal shaft 40enters the hollow interior of the proximal shaft 30 through the slit ofthe penetrating portion 35, which is opened by being compressed.

As illustrated in FIG. 8, the resin material of the distal shaft 40entering the hollow interior of the proximal shaft 30 through thepenetrating portions 35 forms projecting portions 46 penetrating throughthe penetrating portions 35. The projecting portions 46 possess tipportions which are enlarged portions 46 a having a larger width than thepenetrating portions 35. The projecting portion 46 has a shapecontinuing in the circumferential direction of the proximal shaft 30 inthe embodiment illustrated in FIG. 8.

As described above, the catheter shaft 11 of the catheter 10 of thisapplication is configured in such a manner that the proximal shaft 30 onthe proximal side formed into a hollow shape and the distal shaft 40 onthe distal side formed into a hollow shape are joined in the axialdirection. The proximal shaft 30 and the distal shaft 40 are integrated(i.e., integrally joined in an axially overlapping manner orinterconnected) by an end portion of one of the proximal shaft 30 andthe distal shaft 40 inserted into a hollow interior of an end portion ofthe other of the proximal shaft 30 and the distal shaft 40. The proximalshaft 30 may include the penetrating portion 32 which penetrates throughthe proximal shaft 30 in the thickness direction between the innersurface and the outer surface at the end portion of the proximal shaft.The distal shaft 40 may include a projecting portion 45 that penetratesfrom one surface toward the other surface of the proximal shaft throughthe penetrating portion 32. A tip portion of the projecting portion 45exposes from the inner surface or the outer surface of the proximalshaft through the penetrating portion 32 (i.e., penetrates fully throughthe penetrating portion 32 to be exposed on the inner surface or theouter surface of the proximal shaft). Therefore, the projecting portions45 of the distal shaft 40 enter from one surface to the other surface ofthe proximal shaft 30 at the joint portion between the proximal shaft 30and the distal shaft 40, so that separation of joint surfaces of theproximal shaft 30 and the distal shaft 40 from each other may beprevented, and a high joining strength between the proximal shaft 30 andthe distal shaft 40 is achieved. Accordingly, the catheter shaft 11 ofthe catheter 10 of the embodiment illustrated in FIG. 3 may preventseparation of the joint surfaces of the proximal shaft 30 and theproximal shaft 40 from each other and disconnection between the proximalshaft 30 and the distal shaft 40.

The distal end portion of the proximal shaft 30 is inserted into thehollow interior of the end portion of the distal shaft 40, and theprojecting portions 45 of the distal shaft 40 penetrate from the outersurface side to the inner surface side of the proximal shaft 30 (i.e.,radially inward) through the penetrating portions 32 to be exposed atthe inner surface of the proximal shaft 30. Therefore, the projectingportions 45 may be formed while crimping the proximal shaft 30 and thedistal shaft 40 easily by heating and pressing from outside of thedistal shaft 40.

The tip portions of the projecting portions 45 exposing from the innersurface of the proximal shaft 30 have the enlarged portion 45 a having awidth larger than the penetrating portions 32. Therefore, a structure inwhich the projection portions 45 cannot come apart easily from thepenetrating portions 32 is achieved and separation of the joint surfacesof the proximal shaft 30 and the distal shaft 40 from each other anddisconnection between the proximal shaft 30 and the distal shaft 40 maybe prevented further reliably.

The penetrating portions 32 are holes or a slit 35 formed on theperipheral surface of the proximal shaft 30. Therefore, the penetratingportions 32 may be easily formed in the proximal shaft 30.

The proximal shaft 30 is made of a metallic material, and the distalshaft 40 is made of a resin material. The fixation between the proximalshaft 30 and the distal shaft 40 with the projecting portion 45 at ajoint between the metallic material and the resin material by crimpingmay thus be further improved.

The distal shaft 40 may include the balloon 12 on the distal side of thedistal shaft 40. In this case, the interior of the catheter shaft 11 ofthe catheter 10 is pressurized when the balloon 12 is inflated. Thejoining surfaces of the proximal shaft 30 and the distal shaft 40 aresusceptible to separation or the proximal shaft 30 and the distal shaft40 are susceptible to disconnection due to the pressure in the interiorof the catheter shaft 11. However, such separation and disconnection mayreliably be prevented as discussed above.

The reinforcement body 33 extending distally from the distal end portionof the proximal shaft 30 is also provided, and the proximal end portionof the reinforcement body 33 is disposed distal to the penetratingportions 32 or penetrating portion 32 of the proximal shaft 30 disposedat the distal-most position. Therefore, the reinforcement body 33 isprevented from interfering with the projecting portions 45, and thereinforcement body 33 may be extended linearly from the end portion ofthe proximal shaft 30 toward the distal shaft 40. Bending properties ofthe catheter shaft 11 are thus not adversely affected. When joining theproximal shaft 30 and the distal shaft 40, the core bar member 60 may beprevented from interfering with the reinforcement body 33, so that thereinforcement body 33 may be prevented from being deformed.

Note that the catheter of this application is not limited only to theembodiments described above, and various modifications may be made byone of ordinary skill in the art within a technical scope of thedisclosed catheter. For example, in the embodiment described above, thecatheter has the balloon 12. However, configurations that do not have aballoon are also applicable, and configurations on which a stent ismounted on the balloon are also applicable.

In the above-described embodiments, the proximal shaft 30 made of ametallic material and the distal shaft 40 made of a resin material arejoined to one another. However, the distal shaft 40 may further includea plurality of shafts. The proximal shaft 30 may be made of a resinmaterial.

The detailed description above describes a catheter and method ofmanufacturing a catheter. The invention is not limited, however, to theprecise embodiments and variations described. Various changes,modifications and equivalents can be effected by one skilled in the artwithout departing from the spirit and scope of the invention as definedin the accompanying claims. It is expressly intended that all suchchanges, modifications and equivalents which fall within the scope ofthe claims are embraced by the claims.

What is claimed is:
 1. A catheter comprising: a catheter shaft extendingin an axial direction from a proximal end to a distal end, the cathetershaft possessing a proximal side and a distal side; the catheter shaftcomprising a proximal shaft formed into a hollow shape and provided onthe proximal side and a distal shaft formed into a hollow shape andprovided on the distal side of the catheter shaft, the proximal shaftpossessing a distal end, a proximal end, an inner surface and an outersurface, the distal shaft possessing a proximal end, a distal end, aninner surface and an outer surface, the proximal shaft and the distalshaft being joined to one another in the axial direction; the proximalshaft and the distal shaft being integrally connected to one another bythe distal end of the proximal shaft being inserted into a hollowinterior of the proximal end of the distal shaft or by the proximal endof the distal shaft being inserted into a hollow interior of the distalend of the proximal shaft; the proximal shaft comprising a penetratingportion which penetrates from the inner surface through to the outersurface at the distal end of the proximal shaft; the distal shaftincludes a projecting portion that penetrates from the outer surfacetoward the inner surface of the proximal shaft through the penetratingportion or penetrates from the inner surface toward the outer surface ofthe proximal shaft through the penetrating portion when the proximal endof the distal shaft is inserted into the hollow interior of the distalend of the proximal shaft; and the projecting portion comprises a tipportion which extends through the penetrating portion past the innersurface or past the outer surface of the proximal shaft so that the tipportion is exposed.
 2. The catheter according to claim 1, wherein thedistal end of the proximal shaft is inserted into the hollow interior ofthe proximal end of the distal shaft, and the projecting portion of thedistal shaft penetrates from the outer surface to the inner surface ofthe proximal shaft through the penetrating portion to be exposed at theinner surface of the proximal shaft.
 3. The catheter according to claim1, wherein the tip portion of the projecting portion possesses anenlarged portion having a width larger than a width of the penetratingportion.
 4. The catheter according to claim 1, wherein the penetratingportion is a hole or a slit formed to penetrate through the outer andinner surfaces of the proximal shaft.
 5. The catheter according to claim1, wherein the proximal shaft is a metallic material, and the distalshaft is a resin material.
 6. The catheter according to claim 1, furthercomprising: a balloon on the outer surface of the distal shaft, theballoon being distal to the projecting portion.
 7. The catheteraccording to claim 1, further comprising: a reinforcement body extendingdistally from the distal end of the proximal shaft, the reinforcementbody possessing a proximal-most end, a plurality of penetrating portionsare provided in the distal end of the proximal shaft, at least one ofthe plurality of penetrating portions being located distal-most in theaxial direction, and the proximal-most end of the reinforcement body isdistal to the at least one penetrating portion of the proximal shaftthat is distal-most.
 8. A catheter comprising: a catheter shaftextending in an axial direction from a proximal end to a distal end; thecatheter shaft comprising a proximal shaft and a distal shaft; theproximal and distal shafts each being a hollow cylinder; the proximalshaft possessing a distal end, a proximal end, an inner surface and anouter surface, the distal shaft possessing a proximal end, a distal end,an inner surface and an outer surface; the proximal end of the distalshaft being proximal to the distal end of the proximal shaft so that thedistal and proximal shafts overlap in the axial direction along a joint;the proximal shaft and the distal shaft being integrally connected toone another at the joint by the distal end of the proximal shaft beinginserted into a hollow interior of the proximal end of the distal shaft;the proximal shaft comprising a penetrating portion which penetratesfrom the inner surface through to the outer surface at the distal end ofthe proximal shaft; the distal shaft comprising a projecting portionthat extends radially inward from the inner surface of the distal shaft,the projecting portion extending through the penetrating portion of theproximal shaft to the inner surface of the proximal shaft; and theprojecting portion comprising a tip portion which extends radiallyinwardly beyond the inner surface of the proximal shaft.
 9. The catheteraccording to claim 8, wherein the penetrating portion is a hole thatpossesses an inner diameter, the tip portion of the projecting portionpossesses an enlarged portion possessing a width, and the width of theenlarged portion is larger than the inner diameter of the penetratingportion.
 10. The catheter according to claim 8, wherein the penetratingportion is a helical slit formed to penetrate through the outer andinner surfaces of the proximal shaft.
 11. The catheter according toclaim 8, wherein the proximal shaft is a metallic material and thedistal shaft is a resin material.
 12. The catheter according to claim 8,further comprising: a balloon on the outer surface of the distal shaft,the balloon being distal to the projecting portion.
 13. The catheteraccording to claim 8, further comprising: a reinforcement body extendingdistally from the distal end of the proximal shaft, the reinforcementbody being a wire member that possesses a proximal-most end, a pluralityof penetrating portions are provided in the distal end of the proximalshaft, at least one of the plurality of penetrating portions beingdistal-most in the axial direction, and the proximal-most end of thereinforcement body is distal to the distal-most penetrating portion ofthe proximal shaft.